BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-HANDLE WITH QUICK COUPLING

    MDR report key: 6541374 · Received May 3, 2017

    Report

    Report Number
    2530088-2017-10106
    Event Type
    Malfunction
    Date Received
    May 3, 2017
    Report Date
    April 7, 2017
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HWX
    UDI-DI
    10886982187413
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 311.44 WITH LOT NUMBER(S) 5031541 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 27-JUN-2005. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. DHR REVIEW FOR PART #311.44, SYNTHES LOT #5031541. RELEASE TO WAREHOUSE DATE: 27-JUN-2005. MANUFACTURED BY SYNTHES (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE HANDLE BROKE OFF, AND THE DEVICE WAS IN TWO PIECES. THE REPAIR TECHNICIAN REPORTED THE HANDLE WAS BROKEN OFF AT THE T. HANDLE CRACKED/BROKEN IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. A PRODUCT INVESTIGATION WAS COMPLETED: A DEVICE HISTORY RECORD (DHR) REVIEW, SERVICE AND REPAIR EVALUATION, SUPPLIER EVALUATION, VISUAL INSPECTION, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT IS CONFIRMED. REPLICATION OF THE COMPLAINT IS NOT APPLICABLE AS THE DEVICE WAS RECEIVED BROKEN. THE DEVICE WAS RETURNED WITH THE SHAFT OF THE HANDLE BROKEN AT THE DOWEL PIN WITHIN THE HANDLE. THE OVERALL BALANCE OF THE DEVICE OUTSIDE OF THE MALFUNCTION WAS RELATIVELY GOOD CONDITION GIVEN ITS AGE (12 YEARS). ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, IT IS LIKELY THAT THE BREAKAGE WAS AS A RESULT OF EXCESSIVE PRESSURE AND MATERIAL FATIGUE OVER THE 12 YEAR LIFESPAN. HARD BONE MAY HAVE ALSO BEEN A CONTRIBUTING FACTOR TO THE COMPLAINT. PER THE TECHNIQUE GUIDE, THE 311.44 T-HANDLE WITH QUICK COUPLING IS AN INSTRUMENT ROUTINELY USED IN THE 4.5MM AND 6.5MM HEADLESS COMPRESSION SCREWS SYSTEM. THE RELEVANT DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. DURING THE INVESTIGATION NO PRODUCT DESIGN OR MANUFACTURING ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDLE OF A T-HANDLE WITH QUICK COUPLING BROKE OFF. THE DEVICE IS NOW IN TWO (2) PIECES. THE ISSUE WAS FOUND WHILE INSPECTING THE DEVICE DURING STERILE PROCESSING. IT IS UNKNOWN IF THE ISSUE WAS FOUND PRIOR TO OR AFTER STERILE PROCESSING. NO REPORTED ISSUES WITH THE DEVICE PRIOR TO DISCOVERY. NO CASE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) T-HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322936 T-HANDLE WITH QUICK COUPLING TAP,BONE HWX SYNTHES BRANDYWINE 5031541 10886982187413

    Patients

    Seq Age Sex Outcome Treatment
    1